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| ID | Type | Description | Link |
|---|---|---|---|
| JPC-04-356-20 |
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In patients with chronic hepatitis C, the ultimate treatment goal is the improvement of liver histology and inhibition of progression to liver cirrhosis and hepatocellular carcinoma (HCC). These effects are reported to be correlated with sustained ALT improvement. Therefore, the aim of this study is to determine if a low-dose (0.25, 0.5, or 1.0 mcg/kg SC QW) PegIntron monotherapy administered for 12 weeks will result in ALT normalization in Japanese patients with chronic hepatitis C.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.25 Dose Group | Experimental | PegIntron 0.25 mcg/kg SC QW for 12 weeks |
|
| 0.5 Dose Group | Experimental | PegIntron 0.5 mcg/kg SC QW for 12 weeks |
|
| 1.0 Dose Group | Experimental | PegIntron 1.0 mcg/kg SC QW for 12 weeks |
|
| No-treatment Control | No Intervention | No treatment (no placebo) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PegIntron (peginterferon alfa-2b) | Biological | PegIntron 0.25 mcg/kg subcutaneously (SC) once a week (QW) for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients who achieve normalization of ALT in each treatment group | Measured at the end of 12 weeks of treatment or at discontinuation. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: adverse events, adverse reactions, laboratory test result (hematology, blood biochemistry and thyroid function test) | Measured between when the patient signs the informed consent form and the end of post-treatment follow-up |
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Inclusion Criteria:
Patients with chronic hepatitis C patients (CHC) who met all of the following criteria:
Exclusion Criteria:
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| ID | Type | URL | Comment |
|---|---|---|---|
| CSR Synopsis | View IPD |
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| PegIntron (peginterferon alfa-2b) | Biological | PegIntron 0.5 mcg/kg SC QW for 12 weeks |
|
|
| PegIntron (peginterferon alfa-2b) | Biological | PegIntron 1.0 mcg/kg subcutaneously (SC) once a week (QW) for 12 weeks |
|
|
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C417083 | peginterferon alfa-2b |
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